Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

NCT ID: NCT00957255

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-04-30

Brief Summary

Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RCR without augmentation

Rotator cuff repair without OrthoADAPT augmentation

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: PROCEDURE

Standard of care rotator cuff repair

RCR with augmentation

Rotator cuff repair with OrthoADAPT augmentation

Group Type: EXPERIMENTAL

OrthoADAPT

Intervention Type: DEVICE

soft tissue augmentation device

Interventions

OrthoADAPT

soft tissue augmentation device

Intervention Type: DEVICE

Standard of care

Standard of care rotator cuff repair

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ages 18-70
• MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
• Tear is repairable by surgery using protocol prescribed fixation procedure
• Patient is able to sign and IRB approved study informed consent
• Patient is willing and able to return for follow-up appointments and study related procedures
• Patient is willing to comply with prescribed physical therapy regimen

Exclusion Criteria

• Emergency, poly trauma patients
• Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
• Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
• Cervical spine disease
• History of adhesive capsulitis in either shoulder
• Patient whose injury does or may involve litigation
• Diabetics
• Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff
• Patients with grade 3 or 4 glenohumeral arthritis
• Patients with systemic collage disease
• Patients with a known hypersensitivity to equine derived materials
• Active or latent infection
• Chronic use of immunosuppressive agents
• Any oral or IM NSAID usage within 5 days before surgery
• Cancer patients
• Decisional impaired patients
• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synovis Surgical Innovations

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles DePaolo, MD

Role: PRINCIPAL_INVESTIGATOR

Mission Health Research Institute

Pierce Scranton, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Medical Research Foundation

William Bryan, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Center for Orthopedic Surgery

Locations

Seattle Medical Research Foundation

Seattle, Washington, United States

Countries

United States

Other Identifiers

O-0803

Identifier Type: -

Identifier Source: org_study_id